BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GammaPod™ Breast Immobilization and Localization System

    DI: 00850002615074 · Model: Outer Breast Cup · XCISION MEDICAL SYSTEMS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GammaPod™ Breast Immobilization and Localization System
    Primary DI
    00850002615074
    Version / Model
    Outer Breast Cup
    Catalog Number
    XMSGP030A10.00-0.06
    Company Name
    XCISION MEDICAL SYSTEMS, LLC
    Labeler DUNS
    788286941
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-21
    Public Version
    1
    Public Version Date
    2019-03-29
    Public Version Status
    New
    Public Device Record Key
    ca35ec26-6ff6-4892-88cd-39af2b525940

    Device Description

    Small

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IWB System, Radiation Therapy, Radionuclide

    GMDN Terms

    Code Name
    64182 Stereotactic radiotherapy breast positioning system outer cup

    Identifiers

    Type ID
    Primary 00850002615074

    Customer Contacts

    Phone
    1-855-924-7466
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180571 000